Trials / Active Not Recruiting

Active Not RecruitingNCT05063331

Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse

Patient-Centered Outcomes of Sacrocolpopexy Versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse

Status: Active Not Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 300 (estimated)

Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
Sex: Female
Age: 18 Years – 80 Years
Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare two types of surgery for the treatment of uterovaginal prolapse to determine which surgery works best from a patient's perspective and has the lowest number of short-term and long-term complications.

Detailed description

This is a multi-site, randomized controlled trial, where women with the confirmed diagnosis of uterovaginal prolapse will be randomized in a 1:1 ratio to either A) a minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) or B) total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS). After surgery, participants will be followed for 3 years including physical pelvic exams and validated symptom questionnaires to assess for the primary and secondary outcomes. A subset of participants will participate in semi-structured interviews, before surgery and through 2 years after surgery, that will assess patient recovery, satisfaction with care, and calibrate surveyed and clinically assessed outcomes to the daily life experiences of women.

Conditions

Uterine Prolapse

Interventions

Type	Name	Description
PROCEDURE	Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP)	Minimally invasive robotic or laparoscopic supracervical hysterectomy will be done, and the vaginal apex (including cervix) will be suspended utilizing sacrocolpopexy mesh to the anterior spinous ligament.
PROCEDURE	Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)	The uterus will be removed vaginally and the vaginal apex will be suspended utilizing sutures in the uterosacral ligament.

Timeline

Start date: 2021-12-15
Primary completion: 2038-05-31
Completion: 2038-05-31
First posted: 2021-10-01
Last updated: 2026-04-02

Locations

7 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT05063331. Inclusion in this directory is not an endorsement.